Indications And Clinical Use
Methotrexate Injection USP is indicated for Neoplastic diseases:
- Choriocarcinoma: Methotrexate - as single chemotherapy or in combination with other drugs.
- Intermediate, or high-grade Non-Hodgkin's Lymphoma - as part of ProMACE-CytaBOM, ProMACE-MOPP, and Magrath protocols.
- Breast Cancer - as part of CMF (cyclophosphamide-methotrexate-fluorouracil) therapy.
- Acute Lymphoblastic Leukemia - as maintenance therapy.
- Head and Neck Cancer - in combination with other chemotherapies.
- Gastric Cancer - palliative combination chemotherapy.
- Metastasis of unknown primary - as palliative combination chemotherapy.
- Osteogenic sarcoma (adjuvant) - high dose methotrexate with leucovorin rescue (HDMTX-LV)
- Bladder Cancer (advanced) - as part of the M-VAC Regimen.
- Leptomeningeal spread of malignancies (carcinomatosis/leukemia/lymphoma) as a single chemotherapy or alternating with Ara-C
- Burkitt's lymphoma.
- Advanced stages of childhood lymphoma (III and IV, St. Jude's Childrens' Research Hospital Staging System).
- Advanced cases of mycosis fungoides (cutaneous T-cell lymphoma).
Methotrexate Injection USP is indicated as a Disease Modifying Antirheumatic Drug (DMARD) in the following diseases where standard therapeutic interventions fail:
- Severe disabling psoriasis/psoriatic arthritis
- Severe disabling rheumatoid arthritis (RA)
- Severe disabling seronegative arthritides.
In the treatment of psoriasis, Methotrexate Injection USP should be restricted to severe recalcitrant, disabling psoriasis, which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established after dermatologic consultation.
Geriatrics (≥65 years of age): The clinical pharmacology of methotrexate has not been well studied in older individuals. Due to diminished hepatic and renal function, as well as decreased folate stores in this population, relatively low doses should be considered, and these patients should be closely monitored for early signs of toxicity.
Pediatrics (<18 years of age): Safety and effectiveness in pediatric patients have not been established, other than in cancer chemotherapy. Therefore, Methotrexate Injection USP should not be used as a DMARD in pediatric patients.